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K Number
K072621
Device Name
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC
Date Cleared
2007-12-13

(87 days)

Product Code
BZT
Regulation Number
868.1920
Type
Traditional
Panel
AN
Reference & Predicate Devices
K864043,K864044
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Esophageal/Rectal Temperature Probe, Catalog Numbers 483M-9, 483M-12, and 491B: The CSZ sesphageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or medal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.

Boohageal Stethoscope with Temperature Sensor, Catalog Numbers 493M-9, 493M-12, 493M-18, and 493M-24: The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal caperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.

Device Description

Disposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor s processed and displayed by the monitoring unit.

AI/ML Overview

The provided text describes a 510(k) submission for Esophageal/Rectal Temperature Probes and Esophageal Stethoscopes with Temperature Sensors. This submission focuses on demonstrating substantial equivalence to predicate devices and does not detail an AI device or a study involving acceptance criteria for AI performance. Therefore, I cannot generate the requested information based on the provided text.

The document discusses:

  • Device Name: Esophageal/Rectal Temperature Probe, and Esophageal Stethoscope With Temperature Sensor Probe
  • Manufacturer: Cincinnati Sub-Zero Products, Inc. (CSZ)
  • Intended Use: Continuous measurement of core body temperature through the esophagus or the rectum.
  • Comparison to Predicate Devices: Smiths Level 1 Esophageal/Rectal Temperature Probe and Esophageal Stethoscope With Temperature Sensor Probe.
  • Non-clinical Tests: Testing was done in accordance with BS EN 12470-4, Clinical Thermometers.
  • Conclusion: The CSZ products meet the requirements of EN 12470-4 for Clinical Electronic Thermometers, and are therefore considered as safe and effective as the predicate device.

None of this information pertains to an AI device, its acceptance criteria, or related studies.

§ 868.1920 Esophageal stethoscope with electrical conductors.

(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).